Teva's Denosumab-Adet (Degevma) Approved as Xgeva Biosimilar

Teva Pharmaceutical Industries said FDA has approved denosumab-adet (Degevma) as a biosimilar to denosumab (Xgeva; Amgen) across all of the reference product's indications, the company announced September 28, 2026.¹

"The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine," said Thomas Rainey, senior vice president, US Biosimilars at Teva, in a company press release.¹ "The approval of DEGEVMA is a powerful example of Teva's Pivot to Growth strategy in action because it represents an important step in expanding treatment options for patients and supporting healthcare systems with a high-quality biosimilar."

What does the Degevma approval cover?

Degevma is approved to prevent skeletal-related events in adults with multiple myeloma or bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgery is likely to cause severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. FDA based its approval on a totality of evidence, including analytical and clinical data showing no clinically meaningful differences from Xgeva in safety, purity, and potency.¹

Independent peer-reviewed data illustrate the kind of evidence this pathway relies on. A phase 3 trial of a different denosumab biosimilar in 850 patients with bone metastases from solid tumors found equivalent reductions in a bone-turnover marker and comparable skeletal-related-event rates and safety versus reference denosumab.²

"Our R&D mission is grounded in a clear commitment: translating complex biologic science into high-quality treatment options that address patient needs," said Rob Cook, PhD, head of global technical development and generics R&D at Teva, in a company press release.¹ "The approval of DEGEVMA reflects the scientific, clinical, and regulatory expertise behind our in-house biosimilars capabilities and our continued focus on expanding access to important biologic medicines."

How does denosumab-adet work?

Denosumab-adet is a human monoclonal antibody that binds RANKL, a protein essential to the formation, function, and survival of osteoclasts, the cells that break down bone. By blocking RANKL signaling, it reduces bone resorption and cancer-induced bone destruction; Degevma will be supplied as a 120 mg/1.7 mL solution for injection.¹ Denosumab's underlying efficacy in this setting was established in a randomized, double-blind trial that found denosumab delayed skeletal-related events versus zoledronic acid in patients with bone metastases from solid tumors or multiple myeloma.³

What does this mean for Teva's biosimilar portfolio?

Degevma is Teva's second FDA-approved biosimilar in 2026, following Ponlimsi (denosumab-adet), a biosimilar to Prolia (denosumab) that FDA approved in March 2026 for osteoporosis and related bone-loss indications.¹^,⁴ These 2 products give Teva a denosumab biosimilar portfolio spanning both reference products' indications, from cancer-related bone complications to osteoporosis.¹

Degevma has been approved in the European Union since November 18, 2025, and Teva said it anticipates launching both Degevma and Ponlimsi in the United States in the coming months.¹ According to Teva, biologics such as denosumab account for a significant share of health care spending, particularly in oncology, and Teva has framed biosimilar competition as a way to lower those costs while broadening patient access to complex, life-enhancing medications.¹

What are the limitations?

The press release does not specify whether Degevma has been granted FDA interchangeability designation, which affects whether pharmacists can substitute it for Xgeva without prescriber involvement under state law. As with other biosimilars, FDA approval relies on demonstrated analytical and clinical similarity to the reference product across indications rather than new large-scale outcomes trials in each one. Teva's launch timeline does not specify a firm date. Pricing and payer coverage details, which will shape actual cost savings for patients, were not disclosed.

References

1. Teva Pharmaceutical Industries. Teva continues biosimilar momentum with U.S. FDA approval of Degevma (denosumab-adet), a biosimilar to Xgeva (denosumab). Press release. Published September 28, 2026. Accessed September 30, 2026. https://www.tevapharm.com/news-and-media/latest-news/teva-continues-biosimilar-momentum-with-u.s.-fda-approval-of-degevma-denosumab-adet-a-biosimilar-to-x
2. Zhao M, Hu X, Zhuang P, et al. A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva) in patients with bone metastasis from solid tumors. J Bone Oncol. 2025;51:100661. doi:10.1016/j.jbo.2025.100661
3. Henry D, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29(9):1125-1132. doi:10.1200/JCO.2010.31.3304
4. Teva Pharmaceutical Industries. Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab). Press release. Published March 30, 2026. Accessed September 30, 2026. https://www.globenewswire.com/news-release/2026/03/30/3264544/0/en/Teva-Gains-Biosimilar-Momentum-with-U-S-FDA-Approval-of-PONLIMSI-denosumab-adet-and-Dual-Filing-Acceptance-for-Biosimilar-Candidate-to-Xolair-omalizumab.html